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Instant Warm Gel Pack

by Prism Technologies, Inc.

510(k) K912715

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912715 Date2 Oct 1991ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1301-2015 FDA Class II initiated 26 Jan 2015
    • Terminated Z-1299-2015 FDA Class II initiated 26 Jan 2015
    • Terminated Z-1300-2015 FDA Class II initiated 26 Jan 2015
    • Terminated Z-1298-2015 FDA Class II initiated 26 Jan 2015

    Products without expiration date have the remote potential for minor burn

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IMD
Device Class
Class I
Regulation
21 CFR Part 890.5710
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Prism Technologies, Inc.

  • Mityvac

    Class II

  • Coldgel

    Class I

  • Transwarmer

    Class I

  • Instant Coldgel

    Class I